MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Model Number CLINIMACS PLUS INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Insufficiency (2022); Respiratory Distress (2045); Chest Tightness/Pressure (2463); Pericardial Effusion (3271)

Event Date 09/27/2016

Event Type  Injury  

Event Description

Pt is a (b)(6) y/o male with history of recurrent hodgkin lymphoma.He received a tcr-alpha/beta and cd19 depleted haploidentical stem cell transplant on (b)(6) 2016.The pt was seen in clinic for routine f/u and had been experiencing chest discomfort with deep breaths and worsening cough.The pt was admitted to the inpatient unit on oxygen.Echocardiogram showed pericardial effusion, with concern for tamponade.Chest ct showed worsening upper lobe predominant ground glass opacities.Cardiology did not feel pericardiocentesis was needed emergently, but, performed it next morning and drain placed.The following day ((b)(6) 2016), there was reaccumulation of the effusion, suspected to be a blockage which was resolved with flushing.Echo on ( (b)(6) 2016 showed trivial effusion.Cardiac mri on (b)(6) 2016 showed constrictive pericarditis.Drain was removed on (b)(6) 2016.Repeat echo on (b)(6) 2016 showed no pericardial effusion.Cardiology recommended repeat echo in 2 weeks.The pt was discharged and is so far clinically stable as an outpatient.We are reporting this event because it was a serious adverse event that is relatively unexpected with the transplant regimen.We suspect that the reason for this complication might be a combination of his prior and recent chemo/radiation.We do not feel the device (clinimacs column) to be related at all.However, given the fact that the ide encompassed the entire conditioning regimen, we are still reporting this event.

• Brand Name: CLINIMACS PLUS INSTRUMENT
• Type of Device: CLINIMACS PLUS INSTRUMENT
• Manufacturer (Section D): MILTENYI BIOTEC GMBH
• MDR Report Key: 6030470
• MDR Text Key: 57680642
• Report Number: MW5065401
• Device Sequence Number: 1
• Product Code: OVG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CLINIMACS PLUS INSTRUMENT
• Device Catalogue Number: 151-01
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACYCLOVIR; ALBUTEROL; AMBIEN; AUTOLOGOUS STEM CELL; AZITHROMYCIN; BACTRIM; BRENTUXIMAB; BUDESONIDE-FORMOTEROL; CARBOPLATIN; CARVEDILOL; COLCHICINE; COMPAZINE; ETOPOSIDE CHEMOTHERAPY; FLUCONAZOLE; FUROSEMIDE; IBUPROFEN; IFOSFAMIDE; LEVOTHYROXINE; LIDOCAINE-PRILOCAINE; LISINOPRIL; LOPERAMIDE; MONTELUKAST; NIVOLUMAB; OXYBUTYNIN; OXYCODONE; PREDNISONE; RADITION; RANITIDINE; SIROLIMUS
• Patient Outcome(s): Hospitalization
• Patient Age: 29 YR
• Patient Weight: 156